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Ethicon Media Monitoring 6/26/2017
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Women Left 'Scarred' After Vaginal Mesh Implants
Jun 26, 2017 | BBC
By Marie-Louise Connolly & Catherine Smyth
A group of women in Northern Ireland have said they have been left physically and mentally scarred after having vaginal mesh implants. -
NHS Hernia Mesh Repairs 'Leaving Patients in Chronic Pain'
Jun 26, 2017 | BBC
By Anna Collinson
NHS England is using mesh to repair hernias which leaves many patients in chronic pain, surgeons have told the BBC's Victoria Derbyshire programme. -
Vaginal Mesh Led to 'Excruciating Pain'
Jun 26, 2017 | BBC
By Marie-Louise Connolly & Catherine Smyth
Pain is etched across her face, her body is stiff as she slowly eases herself into a seat. The Belfast woman appears to be in agony and a lot older than her years. -
Protect Innovation by Making FDA Compliance Admissible
Jun 23, 2017 | Law 360
By Lisa Dwyer and Matthew Wetzel
In a few short weeks, the U.S. Supreme Court has the chance to decide whether to hear a product liability case with wide-ranging implications for the medical device industry, and more importantly, for Americans’ continued access to often life-saving medical technology. -
Talc Cases Will Likely Stay in MO Despite Supreme Court Decision, Says Lead Lawyer
Jun 24, 2017 | Mesh Medical Device Newsdesk
A Missouri judge declared a mistrial Monday, June 19, in a lawsuit filed by the estates of three women who had died from ovarian cancer, allegedly after using Johnson & Johnson’s talc-based hygiene products. -
Texas Couple Blames Physiomesh for Revision Surgery
Jun 23, 2017 | Legal Examiner
By Roopal Luhana
A Texas couple filed a lawsuit against Physiomesh manufacturer Ethicon and parent company Johnson & Johnson on May 11, 2017.
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Women Left 'Scarred' After Vaginal Mesh Implants
Jun 26, 2017 | BBC
By Marie-Louise Connolly & Catherine Smyth
A group of women in Northern Ireland have said they have been left physically and mentally scarred after having vaginal mesh implants.
One of them has been left in such pain she said she had considered taking her own life.
The women are now starting legal action for claims of medical negligence.
The mesh or tape implants are used by surgeons in an operation to treat organ prolapse and urinary incontinence, which can be common after childbirth.
The Department of Health said it is "recognised that women who have undergone these procedures may experience complications, as is the case with any surgical procedures, and these symptoms can be distressing".
"It is essential that clinicians that conduct these operations carry out audits to ensure they are performing to the highest possible standards."
The UK's medical products regulator said the current evidence was that the devices are "acceptably safe" if used "properly and as intended."
Mary Morris was 50 years old when she had the operation in 2013. Far from curing her incontinence, she said, it left her in excruciating pain.
"Whenever I was walking I could feel the mesh coming out of my inner thigh. It was like a saw cutting into me, hot and burning. My actual skin had ripped open and was bleeding. That was it eroding."
The mother of three has now had the implant partially removed but explained that she is still suffering.
"I just got that low at times that I didn't want to live. I am a very strong person but it has ruined my family life. I have a young son who is autistic and I could not look after him. I have to get my daughter to do everything for me. I am in severe pain - it's horrendous."
The mesh is made of polypropolene which is a type of plastic. It has been used for a long time in operations - surgeons routinely use it in hernia repair, for example.
Its use as a vaginal implant for the treatment of incontinence is common in Northern Ireland.
Figures seen by the BBC show that in four out of the five health trusts it was used in more than 4,300 such operations from 2006 to 2016.
The procedure uses the mesh as a type of sling or hammock to hold up the internal organs and prevent leakage of urine.
Incontinence after childbirth is a big problem.
Judging how many women are affected is difficult, however, a medical study carried out in 1998 showed that the condition was sufficiently severe to require sanitary protection in over 12% of women aged 35 to 74 in Northern Ireland.
Dr Robin Ashe is a retired consultant gynaecologist at the Antrim Area Hospital. He said that the vaginal mesh and tape operations are a "safe and effective procedure" - as long as they are done in the correct circumstances and by people who are trained in the use of the device.
"Urinary incontinence is very common and is very debilitating and people are living miserable lives. This is an operation which turns around a life. It is effective in over 80% of cases."
"But I do acknowledge that these very unfortunate patients have developed long term problems, or seemingly long term problems and that is distressing."
That some women experience painful and long-lasting complications after this procedure is a story that is replicated across the UK.
The local health trusts, the board and the Public Health Agency turned down BBC NI's offer to be interviewed on the issue.
The Scottish government set up an independent review group looking at the safety of mesh implants in 2014 after women, several of whom were in wheelchairs, gave evidence to the Holyrood Petitions Committee.
An interim report was delivered in October 2015 and the final conclusions are expected to be published soon. More than 20,000 women in Scotland have had the operation over the past 20 years.
Data obtained by BBC One's Victoria Derbyshire programme shows that between April 2007 and March 2015, more than 92,000 women had vaginal mesh and other types of tape implants. About one in 11 has experienced problems, the figures suggest.
Figures obtained by BBC News NI from the body that manages negligence and other claims against the NHS in England, reveal that in a group action of 31 cases which relate to the use of mesh without full consent four have been settled with damages paid of £327,798.
Six have received interim payments of £30,000 but have not yet settled.
In seven other cases of medical negligence, damages have been paid of £204,000 while 18 claims have been closed without the payment of damages and 21 claims remain open.
http://www.bbc.com/news/uk-northern-ireland-40379675
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NHS Hernia Mesh Repairs 'Leaving Patients in Chronic Pain'
Jun 26, 2017 | BBC
By Anna Collinson
NHS England is using mesh to repair hernias which leaves many patients in chronic pain, surgeons have told the BBC's Victoria Derbyshire programme.
The concerns come after it emerged that more than 800 women are taking legal action against the NHS over the use of vaginal mesh implants.
One woman said she was left "screaming on all fours from the agonising pain".
NHS England said mesh implants had been successfully used to treat hernias for several decades.
The material is its "recommended method" for treating the condition. It is used on tens of thousands of patients every year.'Fiery burning agony'
A hernia occurs when an organ or fatty tissue pokes through a gap where muscle has weakened. It most commonly takes place in the groin.
The use of mesh involves pushing bulging tissue back into the abdomen and covering it with the material, and can be delivered via open or keyhole surgery.
Leila Hackett had an umbilical hernia mesh repair in 2013.
"Straightaway I could feel the mesh," she said. "It was like somebody scratching you from inside your body, it's so unpleasant and constant.
"It started off like fiery burning agony but it never stopped hurting or itching."
The mother-of-two spoke to her GP about her pain many times, but was told the mesh was not the problem.
Two years later, she was taken to hospital after the material had become stuck to her internal organs, causing her bowel to twist.
"The pain got so agonising I was just screaming on all fours," Mrs Hackett explained.
During her operation, the surgeon spent four hours picking the material out.
"As soon as I came round, I knew the mesh had been removed because I felt normal again," she said.
ne in 10 people will develop a hernia, and some experts are concerned about the "thousands of hernia mesh patients who are living with chronic pain".
Former general surgeon, Peter Jones, from Kent, spent much of his career removing mesh from British groin hernia patients.
"Severe pain is a common problem and patients aren't being warned about it," Mr Jones said.
"At least half of patients who have a mesh repair will have a smooth recovery, but in my opinion the risks of a poor outcome are so bad, I wouldn't want to take that risk.
"I think litigation will come into this. If enough people got together and said, 'We are suffering and we weren't warned about it', that could put a dent into the mesh repair for hernias."
Martin Kincey, 39, started experiencing pain in 2011, 12 years after he had a mesh repair for his inguinal hernia.
"I used to play all sorts of sports," he explained. "But now the simplest of movements can be seriously painful. It feels like I have been stabbed with something hot."
Martin has had multiple scans, blood tests and colonoscopies, which have all come back clear.
"They've ruled out everything this could be, other than pursuing the mesh complications," he said.
"There must be thousands of people who are experiencing pain who don't realise it could be the mesh.
"It might not be to blame, but until it's investigated, how can we know?"
While studies show 10% to 15% of groin hernias patients will experience chronic pain following a repair, surgeons say more research is needed for less common hernias.
Mesh-free alternative
There is a mesh-free alternative for patients with groin hernias, which some surgeons have called for the NHS to teach its staff, so patients can have a choice.
The Shouldice hernia repair involves a surgeon overlapping and securing layers of the abdominal wall, once a bulge has been placed back inside a patient's body.
The technique was created at the Shouldice Hernia Centre in Toronto, which has a 99.5% lifetime success rate for treating first-time groin hernias.
According to NHS Choices, 10% of hernias come back at some point after surgery.
However, NHS England said the Shouldice repair was hard to replicate in its hospitals.
It said mesh repairs had been undertaken extensively and successfully in the UK for several decades.
The Royal College of Surgeons said while "any poor outcomes are regrettable", mesh implants were the "most effective" way to deal with a hernia.
http://www.bbc.com/news/health-40132638
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Vaginal Mesh Led to 'Excruciating Pain'
Jun 26, 2017 | BBC
By Marie-Louise Connolly & Catherine Smyth
Pain is etched across her face, her body is stiff as she slowly eases herself into a seat. The Belfast woman appears to be in agony and a lot older than her years.
"I have come out partially disabled. I went in able bodied and I have come out in crutches. I am mentally wrecked; I don't know what is going to happen down the line," she said.
"I don't know what the diagnosis is, I don't know what the prognosis is, but I do know that if the pain keeps continuing on like this I am going to end up in a wheelchair."
After a routine smear test, Susan was advised that she had a prolapse. This explained why she leaked urine every day.
A vaginal prolapse is a condition in which structures, such as the uterus, rectum, bladder, urethra, small bowel or the vagina, itself may begin to prolapse, or fall out of their normal positions.
Susan says she dreaded going out shopping and seeking the nearest public toilet when out and about became routine.
"Everyday life was impossible. At times standing became unbearable, running and playing with my daughter impossible," she said
According to Susan, while a consultant advised having an implant, she was never informed of the potential problems.
"I was never advised, for instance, that it was actual mesh. I wasn't given any leaflets to say of the side effects or anything like that.
"I did ask questions, I did ask about the side effects and was there anything I needed to worry about and I was told there wasn't."
Susan's problems emerged almost immediately after the procedure.
In fact she left hospital in tremendous pain and said during the past 12 months she has been passed round several specialists. She said part of the problem is convincing people that there is something wrong.
The 51-year-old said she has been told by specialists not to be frightened of her pain and to try to live and work through it.
As a result she is taking various medications that make her physically sick.
"The pain changes day to day. It (the mesh) can cut into your groin where it is like barbed wire gripping you. I have had pain right down my legs. My hip often gives way when I am walking," she said
Susan said she wants the mesh removed.
Sitting close by is 58-year-old Yvonne McIntosh.
She had vaginal mesh inserted four years ago to try and fix incontinence. While it was a success at the start, she said it now feels like it is starting to unravel inside her body.
"I have been having excruciating pain. I have felt something within me is coming out and would have to go into the bathroom to push it up," she said.
"My husband could also feel it when we were being intimate - he said he could feel something sharp."
A mother of three, Yvonne said it feels like it is making its way out of her body and coming through her groin. Even while talking to me she is shifting in her seat in constant discomfort.
"Every day I am in absolute agony because this is an alien thing that I know is inside me. It feels sharp and is sticking into me when I walk.
"It's not meant to be there - I know there is something wrong."
Yvonne also is seeking help to have it removed but, like other women who have spoken to the BBC, her local health trust says it cannot help her and she has been forced to turn to a private doctor in London instead.
"I have told my consultant how bad it is and she says she can't remove it at all. She can snip it but she is not qualified to remove it, that it is not her field. She mentioned that she could send me to a woman in London instead," she said.
http://www.bbc.com/news/uk-northern-ireland-40386726
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Protect Innovation by Making FDA Compliance Admissible
Jun 23, 2017 | Law 360
By Lisa Dwyer and Matthew Wetzel
Note: Lisa M. Dwyer is a partner with the law firm of King & Spalding LLP, based in Washington, D.C. Matthew E. Wetzel is vice president and assistant general counsel at AdvaMed (the Advanced Medical Technology Association), the world's largest medical technology trade association.
In a few short weeks, the U.S. Supreme Court has the chance to decide whether to hear a product liability case with wide-ranging implications for the medical device industry, and more importantly, for Americans’ continued access to often life-saving medical technology.
The case — Ethicon v. Huskey — raises a simple but critical question: may a medical device maker defend itself against charges of placing a defective product into the marketplace by introducing evidence related to the U.S. Food and Drug Administration’s review and authorization of that product?
The lower court decisions in Ethicon reflect an alarming trend of judicial policymaking that unfairly discriminate against medical device companies by preventing them from introducing this important evidence, based on a fundamental misunderstanding of the FDA’s role in authorizing the marketing of medical devices. If this trend continues, it could chill medical product innovation.
By way of background, the FDA places medical devices into one of three risk-based classes, and each class is subject to different levels of oversight. Class I devices, such as dental floss, are subject to the fewest regulatory controls; Class II devices, such as daily wear contact lenses, require greater regulatory controls; and Class III devices, such as replacement heart valves, require meeting the most stringent regulatory controls.
The highest-risk devices require a rigorous premarket approval application (PMA), and the FDA will approve the product if the evidence shows that there is “reasonable assurance of safety and effectiveness” for the product’s intended use. Low- and moderate-risk devices often require premarket notifications, known as 510(k)s. The FDA will clear a 510(k) when the device is shown to be “substantially equivalent” to a device already on the market.
Many of the lowest-risk devices are exempt from FDA review. The vast majority of devices that are subject to FDA review are authorized for marketing through the 510(k) process. Although the 510(k) process is less rigorous than the PMA process, according to FDA, “the principles of safety and effectiveness underlie the substantial equivalence determination in every 510(k) review.”
And, in fact, the law provides that a 510(k) application may be cleared only if “the device is as safe and effective as a legally marketed device,” and “does not raise different questions of safety and effectiveness.”
Despite the safety and effectiveness principles underlying every 510(k) review, the district judge in Ethicon prohibited the medical device manufacturer, which was defending itself against allegations of selling an unsafe product, from introducing evidence of its compliance with FDA’s 510(k) requirements. The district judge concluded — as is becoming a critical and inappropriate trend — that this evidence would be of limited value and could potentially confuse jurors.
On appeal, the Fourth Circuit agreed, concluding that allowing companies to defend themselves with such evidence raises a “risk [of] confusing the jury by ... causing a battle of the experts over the robustness of the 510(k) process's safety examinations.” The Fourth Circuit also opined that introducing such evidence could result in “wasted time.”
Similarly, in Cisson v. C.R. Bard, the Fourth Circuit also refused to allow another manufacturer to introduce evidence regarding 510(k) compliance based on the erroneous assumptions that 510(k) compliance has limited evidentiary value, and the evidence could confuse the jurors and subject them to “many hours, and possible days, of complex testimony about regulatory compliance.”
The district judge’s and Fourth Circuit’s distorted view is based — in part — on a misunderstanding of the Supreme Court’s 1996 decision in Medtronic v. Lohr. Lohr focused on whether 510(k) clearance can preempt a design defect claim brought under state law — not on whether a 510(k) clearance can be admitted into evidence.
For medical devices, the relevant preemption provision in the law is concerned with conflicting state and federal “requirements.” Based on that provision, the high court in Lohr decided that the 510(k) clearance at issue did not create sufficiently concrete federal “requirements” to merit preemption of the state design defect claim. But the preemption provision at issue in Lohr is not relevant to determining whether 510(k) clearance is admissible. Therefore, the lower courts’ reliance on the Lohr decision is misplaced.
In addition, although compliance with FDA review and clearance processes should always be an admissible fact, courts should recognize that not all 510(k) clearances are created equal. Some 510(k) clearances are based on more safety data than others, and in fact some 510(k) clearances take product-specific clinical data into consideration.
Once evidence of 510(k) compliance is admitted, its probative value in the case should turn on the reason it was admitted and the facts specific to the individual product’s clearance. But one way or another, such evidence should be put in front of the jury.
The Supreme Court is ideally positioned to remedy this situation. Although it is important to resolve legitimate product liability claims justly and swiftly, preventing companies from fully defending themselves — especially in the face of serious, significant allegations of wrongdoing — is fundamentally unfair. Medical device makers, like all defendants, are entitled to full and robust defenses.
Compliance with FDA review and clearance requirements should always be an admissible fact — especially when a fact-finder is exploring whether a company put an unsafe product on the market. Decisions like Ethicon dismiss the value of FDA review in the first place and could enable judges and juries to substitute their own judgment for the FDA’s, without the benefit of having full facts.
Such decisions could also incentivize meritless lawsuits (not to mention advertisements from the plaintiff’s bar encouraging them), thereby further diverting company resources and attention from developing innovative and often life-saving technologies.
In brief, courts should not be permitted to hinder companies’ ability to defend themselves, or shun FDA decisions and expertise, in pursuit of an easy answer. We urge the Supreme Court to step in by granting a writ of certiorari in Ethicon v. Huskey.
https://www.law360.com/articles/937674/protect-innovation-by-making-fda-compliance-admissible
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Talc Cases Will Likely Stay in MO Despite Supreme Court Decision, Says Lead Lawyer
Jun 24, 2017 | Mesh Medical Device Newsdesk
A Missouri judge declared a mistrial Monday, June 19, in a lawsuit filed by the estates of three women who had died from ovarian cancer, allegedly after using Johnson & Johnson’s talc-based hygiene products.
Judge Rex Burlison, in the 22nd Circuit Court in St. Louis, granted the J&J motion for a mistrial after a U.S. Supreme Court 8-1 decision that dealt a blow to injured consumers and their law firms by limiting where their complaints against companies can be heard.
The Supreme Court decision was based on another issue, in another court – the blood-thinner Plavix, a drug made by Bristol-Myers Squibb Co. The court ruled California courts are the proper venue only for claims made by Californians, essentially eliminating what’s known as forum shopping. MND has more on the mistrial here.
The California Supreme Court allowed the proceedings in California because Bristol had sold more than 180 million Plavix pills in that state which generated more than $900 million in sales, reports the Wall Street Journal.
Also the distributor for Plavix is located in California, however, it is not the only distributor of Plavix.
Judge Samuel Alito said that was not enough to allow plaintiffs to consolidate in favorable courts calling it, “a loose and spurious form of general jurisdiction.”
The plaintiffs did not use the drug in California, and were not injured there either. Therefore that “does not allow the state to assert specific jurisdiction over the nonresidents’ claims.”
Justice Sonia Sotomayor was the only dissenting vote.
She wrote, “There is nothing unfair about subjecting a massive corporation to suit in a state for a nationwide course of conduct that injures both forum residents and nonresidents alike.”As soon as the Monday morning Supreme Court decision came down, the lawyer who represented the plaintiffs in the latest St. Louis talcum powder- ovarian cancer trial, says Johnson and Johnson counsel broke out in celebration in the open courtroom in front of the families of the deceased plaintiffs.
TED MEADOWS and the FUTURE OF TALC CASES
Ted Meadows, represented the estates of the late plaintiffs in women in the Missouri wrongful death cases of Swann, et al. v. Johnson & Johnson, et al., No. 1422-CC09326-01.
He told Mesh News Desk he is optimistic the litigation can go forward in Missouri courts.
His team at Beasley Allen, the lead law firm in talc/cancer litigation, will conduct additional discovery and depositions to support that position.
“We were starting week two of evidence after picking the jury the previous week. It was supposed to be a six-week trial. When the Supreme Court decision came down redefining the specific jurisdiction in the country, it put into question whether or not our previous basis for establish jurisdiction was enough.
“The judge felt like we were still less than one-third of the way through the trial, it would be more efficient to grant the defendant’s motion for a mistrial and give us time to conduct discovery for a full briefing whether we have jurisdiction in Missouri, then go through the entire trial.”
A J&J spokeswoman, Carol Goodrich said in a statement the company applauds the judge’s decision.
“Johnson & Johnson consistently and repeatedly objected to the lack of jurisdiction, argued that the trials should not go forward and urged a stay of proceedings because there was no jurisdiction.”
Meadows says there is reason to believe Missouri is the proper venue because a the bottling company for Johnson & Johnson and Imerys Talc America, a San Jose, Ca.-based talc mining company and the only supplier of talc, is based in Missouri.
Pharma Tech, is in Union, Missouri. Pharma Tech is not currently named as a defendant in this case.
See MND on Where is Talc Mined here.
Essentially, Meadows believes the SCOTUS decision provides a roadmap for what needs to be included in this and future complaints.
Judge Burlison is a solid judge, says Meadows, who doesn’t agree with this decision.
“I think it’s an especially incorrect in a modern world where corporations are all over the place. They are capable of being all over the place on internet, mass marketing.”
Missouri Joinder Rules
There are 1,700 pending talc lawsuits pending in Missouri.
Plaintiffs allege the company withheld knowledge about talc’s link to cancer, specifically ovarian cancer. In Missouri, the joinder rules allow for nonresident plaintiffs to file lawsuits in mass tort cases there if they suffer from similar circumstances related to the defendant corporation.
Meadows is confident they will be able to complete discovery and establish that Missouri is the proper jurisdiction. Judge Burlison apparently has some confidence too. He has set October for the date for this trial to continue.
This was only the second victory for J&J in the Missouri courtroom, which has been the venue for more than $300 million in plaintiff awards in four of the previous five talc trials in St. Louis. Most of the awards come from punitive damages.
Meadows believes litigation can continue in the St. Louis court, but if not, new venues can be sought.
On the broader issue of jurisdiction, interestingly, Bristol-Myers Squibb is incorporated in Delaware, where corporations enjoy favorable tax laws and a bias against regulation, even though its businesses are in New York and New Jersey, raising questions about its own chosen venue for incorporation.
Meanwhile, talc litigation continues.
The next talc trial is set for an evidentiary hearing next week with jury selection set for July 10 in Los Angeles. There is just one plaintiff on trial, Eva Echeverria, a woman from California (Case No. BC628228, in Superior Court of California, Los Angeles Co).
Courtroom View Network plans to webcast those proceedings gavel-to-gavel as it did for the recent trials in Missouri.
http://www.meshmedicaldevicenewsdesk.com/talc-cases-will-likely-stay-mo-despite-supreme-court-decision-says-lead-lawyer/
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Texas Couple Blames Physiomesh for Revision Surgery
Jun 23, 2017 | Legal Examiner
By Roopal Luhana
Note: the author of this piece, Roopal Luhana, is an attorney with Chaffin Luhana LLP.
A Texas couple filed a lawsuit against Physiomesh manufacturer Ethicon and parent company Johnson & Johnson on May 11, 2017. They claim the Physiomesh Flexible Composit Mesh, which is used to repair hernias, caused serious injuries to the wife, who was implanted with the product. They seek in excess of $75,000 in damages. The case is pending in the Southern District of Texas.
Plaintiff Blames Physiomesh for Pain and Revision Surgery
According to the complaint, the plaintiff underwent a procedure to repair a hernia on September 19, 2013. A Physiomesh device was implanted into her body at that time.
The FDA first approved Ethicon’s Physiomesh on April 9, 2010. The product is made of a netting material and is designed to be used as a “patch” over areas of weak and stretched muscles and tissues. The outside of the patch contains a material that is supposed to help reduce the risk of inflammation and facilitate fast healing.
A year after the surgery, however, the plaintiff ended up back in the hospital. On June 11, 2014, she had to undergo revision surgery to address complications caused by the Physiomesh. According to the surgeon’s report, he found “numerous balled-up, rolled-up, and incorporated [Physio]mesh,” all of which had to be taken out “with difficulty using cautery and sharp dissection.”
The plaintiff states that she continues to suffer from pain and other complications even after the revision surgery. She blames the manufacturers for creating a faulty product that was not safe or effective.
Physiomesh has been associated with other types of injuries as well, including chronic pain, hernia recurrence, infections, mesh migration, bowel obstructions, improper wound healing, excessive and chronic inflammation, and nerve damage, among others.
Plaintiff Criticizes Multi-Layer Design of Mesh
Physiomesh is compromised of five layers. The two outer layers are made of a “Monocryl” film, the next two of a polydioxanone film, and the center is a polypropylene mesh. The defendants promoted this multi-layer design as a way to prevent or minimize adhesion and inflammation, and encourage incorporation of the mesh into the body.
The plaintiffs allege, however, that this wasn’t the case, and that instead, the multi-layer coating prevented mesh incorporation and caused inflammation, migration, and damage to the surrounding tissues.
She adds that the coating also prevents fluid escape, which leads to the formation of pockets of fluid (seromas) and can cause infection and abscess formation. And when the outer coating degrades, the mesh is exposed and can actually adhere to organs, causing damage.
The plaintiffs claim that the manufacturer failed to provide adequate warnings regarding the risks of its mesh, and brings counts of negligence, design and marketing defect, breach of warranties and misrepresentation. They seek compensatory and punitive damages.
A motion has been filed with the U.S. Judicial Panel on Multidistrict Litigation (JPML) to consolidate all federally-filed Physiomesh lawsuits.
http://newyork.legalexaminer.com/medical-devices-implants/texas-couple-blames-physiomesh-for-revision-surgery/
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